EUCTR2013-003856-19-NL进行中（未招募）1 期
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,282
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Eligible patients who have completed the entire study duration of DRI12544, or who completed the treatment period in the other previous asthma studies.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2011
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •Patients who didn’t complete the DRI12544 study or the treatment period in other previous asthma studies.
- •Patients who have experienced hypersensitivity reactions to dupilumab which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
- •Patients diagnosed with active parasitic infection; suspected or at high risk of parasitic infection, unless clinical and/or laboratory assessments before enrollment have ruled out an active infection.
- •Medical history of human immunodeficiency virus (HIV) infection.
- •Known or suspected medical history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent or prolonged infections, as per investigator judgment.
- •Evidence of acute or chronic infection requiring treatment with antibacterials, antivirals, antifungals, antiparasitics or antiprotozoals within 4 weeks before Visit 1; significant viral infections within 4 weeks before Visit 1 that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment).
- •Patients with any event or laboratory abnormality that, as per Investigator judgment, would adversely affect participation of the patient in this study.
- •Patients who have traveled to parasitic endemic area within 6 months prior to screening.
- •For patients from DRI12544 study, drug induced liver injury related criteria at Screening:
- •- Underlying clinically significant hepatobiliary disease OR
- •- Alanine Aminotransferase (ALT) >3 Upper Limit of Normal (ULN).
- •For patients from DRI12544 study, abnormal lab values at Screening:
- •- Creatine phosphokinase (CPK) >10 ULN OR
- •- Platelets <100.000 cells/mm^3 OR
- •- Eosinophils >1500 cells/mm^3
研究者
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